How to Hire a Clinical Evaluation Report writer for your medical device

Mahasweta Pal, freelance medical writer on Kolabtree, writes about the essential skills medical device companies should look for in a Clinical Evaluation Report writer. 

Dr. Gillian Pritchard, a distinguished member of the European Medical Writers’ Association says that “Clinical evaluation is a structured ongoing procedure to collect, appraise and analyze clinical data pertaining to a medical device.” This clinical data supports the validity of the device applications while including data of the pre-clinical and clinical investigations, risk management, post-market surveillance, and the instructions for use.

Continuing on from our previous article on Clinical Evaluation Reports, we take a look at the top skills the best CER writers should have that make them the right fit for your project.

1. Experienced in implementing the new EU regulations

In particular, for Clinical Evaluation Reports compliant with the EU MDR, regulatory writers need to be aware of the improvements over past reporting guidelines with respect to the analysis of clinical investigations, as well as of post-market surveillance documents. CER specialists are hired basis their expertise in understanding the intricacies of medical device manufacturing, internal safety assessments, and quality control data. In addition, CER writers should be able to address queries on medical device safety, design quality, manufacturing certifications, manufacturer’s instruction for use and other relevant compliance requirements.

The European Union published the new medical device regulations in April 2017. As regards the MEDDEV 2.7/1 Rev. 4, a 5-stage clinical evaluation protocol should be followed by CER writers to enable seamless processing and delivery of a CER.

• Stage 0 – Scope and Plan for New CER
• Stage 1 – Collecting Relevant Data from Multiple Sources (Literature studies, Clinical documents, Manufacturer records, Premarket documents, etc.)
• Stage 2 – Appraisal and Analysis of Collected Data
• Stage 3 – Competitor Analysis, Equivalence analysis
• Stage 4 – Updating CER with Post Market Surveillance (PMS) data & Post Market Clinical Follow Up (PMCF) data

Most importantly, according to the new guidelines, writers need to pay special attention to the requirements of “sufficient clinical evidence”, which means the opportunities, risks, and challenges associated with the clinical development lifecycle of a medical device needs to be presented to be EU MDR compliant.

A Clinical Evaluation Report writer compiles the CER using the below guidance documents:

• MEDDEV 2.7/1 Rev. 4 Annex 1 (published in June 2016, implementation in May 2020 pertaining to the Safety and Performance Evaluation)
• EN ISO 14155:2011 (Clinical Investigation of Medical Devices for Human Subjects and GCP)
• EN ISO 14971:2012 (Clinical Application of Risk Management to Medical Devices)
• MEDDEV 2.12/2 rev2 Post Market Clinical Follow-up – A guide for manufacturers and Notified Bodies (January 2012; to be superseded by MDR Annex XIV).
• NB Med 2.12 Rec1 – Post Marketing Surveillance (February 2000; To be superseded by MDR Annex III).

Depending on the type of medical device, CER writers may have to use the MEDDEV 2.1/6 Quantification and Classification Software. In the case of older devices whose CERs have to be updated according to the EU MDR, usability testing data from clinical investigation reports have to be reported along with device design specifications. A huge requirement for CER writers is analyzing all previous CERs of the selected medical device, comparative studies with the competitor devices, performing gap analyses and establishing the market performance potential of novel medical devices.

2. Effective industry insider

When CER Specialists are industry veterans, their expertise in medical device approvals eases the regulatory journey for manufacturers. A qualified CER expert with a background in Clinical Research Methodology across all therapeutic areas is the manufacturer’s bigwig. An established CER specialist would be a strong networker privy to regulatory meetings. In light of EU’s complex regulatory landscape, the need of the hour is to select CER specialists with experience of dealing with the multitude of regulatory challenges. They would also be best fit for device manufacturers treading into crowded therapeutic areas, e.g., Cardiology, Endocrinology, Oncology, etc.

CER specialists should be regular representatives for their companies at Regulatory & Compliance conferences, global meetings, and seminars that discuss the challenges of medical device safety regulations. In medical device organizations, it is often the case that CER writers have to present the CER to the regulatory panel. Medical Device manufacturers also require CER writers to have a positive reputation with regard to meetings with the Notified Bodies, which makes the CER submission and review a smooth sail. In such cases, CER writers should be chosen who have impeccable communication skills. CER writers that work effectively based on stage-wise project completion goals would be preferred so that the data screening and appraisal functions occur in tandem with the CER preparation. Effectively, a clinical evaluation report writer should guide the quality control team such that the medical device manufacturer achieves its regulatory goals with negligible loss of time.

Medical device manufacturers hire CER writers who have a post-delivery timeline for each of their projects so that the CER writers can provide “active update” reports based on the device’s risk profile. An experienced CER writer should routinely perform literature reviews, check regulatory guidance documents, attend medical device regulation meetings, and develop smarter ways to process CERs without any loss of information. As the EU’s clinical data requirements have expanded, a CER writer that implements effective clinical evaluation strategies by analyzing the MDR & MEDDEV combined directives would be the choice for the long term.

3. Well-versed with scientific literature

The EU MDR requires CERs to be appraised using data on equivalent or similar devices, and routine updates on observational, clinical and experimental research using medical devices. The literature review protocol followed by European CER specialists consists of objective, non-biased, systematic search, and reviews on the patient characteristics, type of intervention, control, and outcome queries. CER writers need to study clinical documents and discuss with cross-functional teams working on risk analysis, enforcing risk management protocols, and abridging the research and development teams according to different insights from the literature studies.

Literature searches, meta-analyses, and clinical evidence collection involve a multitude of reading and analytical skills, and CER writers are expected to master all of them. Therefore, CER writers should be effective readers of medical literature who can streamline the relevant data screening processes. Experienced clinical evaluation report writers with experience in addressing gaps in the clinical evidence, data of adverse events, and relevant queries on preclinical and premarket assessments are preferred.

Manufacturers also need their CER writers to pour into peer-reviewed scientific and clinical reports that show evidence of the device functionality and subsequently, prepare reports presenting the post-market surveillance data. Professional CER writers are also skilled in targeted literature searches on all global reputed scientific literature databases. Efficient data scouting involves navigating MEDLINE, Index Medicus, EMBASE/Excerpta Medica, and the Cochrane Database of Systematic Reviews. The key search strategies used by CER writers drive the quality of the report.

4. Familiar with the Economic Operators Regime

The EU MDR contains an additional regime with respect to economic operators (EO), which involves communication with legal advisors before CE-marking. The EO regime is based on the previous regulation – 765/2008, which details a regulatory template for European Union (EU) legislation regarding medical devices, taking into account the concepts in the functioning of the CE marking system, and all concepts relating to economic operators, such as the core concept of ‘placing on the market,’ ‘making available,’ as well as the economic operators in the product supply chain and their obligations.

Moreover, the MDR and IVDR explicitly define the requirements set for Manufacturers, Authorized representatives, Importers, and Distributors (MAID). The MAID paradigm is an update over the previous MEDDEV directives, detailing the obligations for manufacturers to re-interpret their supply chain and present clearly to the Notified Body the understanding of each person’s role in the medical device supply chain. According to the Blue Guide (a guidance document issued by the European Commission), “Each role of the MAID is defined in the MDR and IVDR along with crucial concepts of ‘placing on the market’ and ‘making available.’ These concepts are determinative for the regulatory responsibilities imposed by the MDR and the IVDR on the various EOs in the medical devices supply chain.”

A clinical evaluation report writer should have some exposure in leading conversations with legal experts handling the obligations of the EO regime, and in providing the relevant documents from the manufacturer’s side as well as the pertinent guidance documents published for every circumstance encountered in the product approval journey. Manufacturers look for CER specialists that can analyze and interpret if and when a product must be RoHS-compliant {according to the Restriction of Hazardous Substances RoHS Directive (2011/65/EC)} or compliant with a new revised standard (e.g., when the 4th edition of Standard for Medical Electrical (ME) Equipment, IEC/EN 60601-1-2:2018 became mandatory for medical electrical products placed on the market from 30 December 2018).

5. Strong analytical and report writing skills

CER writers are also the manufacturer’s go-to persons for previous CE-marked documents since the new MDR directives changed the basis for classifying devices. Hence, CER medical writers are also hired by medical device manufacturers for furnishing reports pertaining to the reclassification of devices and their updated marketing and distribution processes.

Additionally, since clinical evaluation involves stage-wise screening of clinical data and updating data from post-market surveillance reports, CER writers should have experience of clinical data analytics. The ideal CER writer should have delivered at least 50 CERs spanning all major therapeutic areas and be adept at preparing CER deliverables for all types of medical devices.

6. Experience with regulatory affairs (RA)

It is not possible to deliver Clinical Evaluation Reports without being a testified expert in regulatory affairs. CER writers should be skilled in implementing the changes, updates, and improvements of regulatory systems (such as the European Commission, Swissmedic, ANSM, etc.) in their deliverables. Essentially, a Clinical Evaluation Report writer should be an expert on regulatory affairs. With documentation requirements rising, the scope for CER writers keeps diversifying. CER writers are expected to inform manufacturers when their products can have a clinically exempt CER (in case of equivalent manufacturing and supply methodologies, similar literature search, and reporting requirements as listed in MEDDEV 2.7/1 Rev 4).

All CER files should provide explicit information on the device design, features and intended use information, warnings, contraindications, risk management data, and the data sources. The EU MDR requirements involve contractual and QMS-driven implementation of shared economic operator resources, UDI and labeling compliance, post-market clinical follow-up data collection, and the consequences of the Brexit shift and fewer Notified Bodies.

Need to hire a freelance CER writer? Consult qualified experts on Kolabtree. Post your project and get quotes for free.

Related Experts:

Medical Device Consultants | Freelance Medical Writer | Freelance CER Writer | EU MDR Consultants | FDA Submissions | Literature Search Experts | Regulatory Compliance Experts | Clinical Trials Expert | Regulatory Writers | PMS Consultants | PMCF Consultants | Biostatistics Experts | Product Development Expert 

 

References:

1. Hunter J and Yan M. “Challenges in Clinical Evaluation for the EU Versus China.” Regulatory Focus. September 2019. Regulatory Affairs Professionals Society.
2. Study Group 5. “Clinical Evaluation – Final Document.” May 2007. SG5/N2R8 Global Harmonization Task Force.
3. Gillian Pritchard. “Clinical Evaluation Reports from the medical writer’s perspective!”  Journal of Medical Writing; Volume 26, Issue 2 – Medical Devices. June 2017. European Medical Writers Association.